B-379 Analytical Performance of Two Tumor Marker Immunoassays on the Atellica CI 1900 Analyzer

Abstract

Abstract Background The Atellica® CI 1900 Analyzer is an automated, mid-throughput, integrated chemistry and immunoassay analyzer utilizing both Atellica CH and Atellica IM assays. This study was designed to evaluate the analytical performance of the Atellica IM Carcinoembryonic Antigen (CEA) and Alpha Fetoprotein (AFP) assays* on the Atellica CI 1900 Analyzer. Methods The Atellica CI 1900 CEA and AFP assays use the same reagents and calibrators as the comparable Atellica IM assays. Precision and method comparison (MC) were used as performance indicators for the Atellica CI 1900 Analyzer. Precision studies were performed according to CLSI EP05-A3 using quality control, native, and contrived human serum samples. One aliquot of each sample pool was tested in duplicate in two runs per day ≥2 h apart on each analyzer for ≥20 days. MC studies were performed according to CLSI EP09-A3. Individual native and contrived human serum samples were analyzed using the Atellica IM assays on both the Atellica IM and Atellica CI 1900 Analyzers. Results Representative precision and MC results observed for each assay across indicated sample ranges are listed in the table. Slopes determined by the Deming linear regression model were approximately equal to 1. Conclusion Evaluation of the CEA and AFP assays using the Atellica CI 1900 Analyzer demonstrated good precision and equivalent performance compared to the same assays on the Atellica IM Analyzer. *The products/features mentioned here are not commercially available in all countries. Their future availability cannot be guaranteed.